BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 2485275 · Received March 9, 2012

    Report

    Report Number
    1826988-2012-00100
    Event Type
    Malfunction
    Date Received
    March 9, 2012
    Date of Event
    February 1, 2012
    Report Date
    February 10, 2012
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    LFR
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HER BLOOD GLUCOSE USING HER 2 CONTOUR METERS AND RECEIVED READINGS OF 124 AND 66MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVALUATION. REPLACEMENT TEST STRIPS AND A NEW METER WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS BLOOD GLUCOSE TEST STRIPS LFR BAYER HEALTHCARE LLC 7099C 1GC3C15

    Patients

    Seq Age Sex Outcome Treatment
    1